Siemens Dimension HB1C Flex reagent cartridge — Class II medical device recall Z-0420-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2014-12-03, distributed nationwide. Certain lots of the reagent cartridges show confirmed positive bias averaging 0.4% Hemoglobin A1c units and oc
| Recall number | Z-0420-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2014-09-30 |
| Classified | 2014-11-21 |
| Reported by FDA | 2014-12-03 |
| Terminated | 2015-08-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Lot numbers | 13294BA, 13308BA, 13329AA, 13350AA, 14006AA, 14041BA, 14069BB, 14083BA, BA4273, BA4280, BA4287, GA4266, GA4301, GA4315, GA4343, GA4350, GA4357, GA5013, GA5020, GC4322 |
| Model numbers | DF105A, K3105A |
Product
Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long-term glucose control in individuals with diabetes mellitus.
Reason for recall
Certain lots of the reagent cartridges show confirmed positive bias averaging 0.4% Hemoglobin A1c units and occasionally up to 1.0% HbA1c units for patient samples when compared to the National Glycohemoglobin Standardization Program (NGSP). QC samples may exhibit a similar bias.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0420-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.